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New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R)

Saturday, September 20, 2008 General News
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Earlier treatment initiation and longer exposure to Betaseron was associated with improved long-term outcomes in multiple sclerosis



MONTREAL, Sept. 19 /PRNewswire/ -- Data presented at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS) demonstrated that early initiation of Betaseron(R) (interferon beta-1b) treatment had a greater impact on long-term outcomes, when compared to delayed treatment. (i)
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The study, sponsored by Bayer HealthCare Pharmaceuticals, used data from the 16-Year Long-Term Follow-up Study of Betaseron to investigate the relationship between timing of drug initiation and length of exposure to treatment, and long-term outcomes. It demonstrated that initiating Betaseron treatment early in the disease reduced the risk of negative long-term outcomes, including conversion to secondary progressive multiple sclerosis (SPMS), reaching a confirmed EDSS of 6.0 or the use of a wheelchair. The study also found that the longer patients stayed on treatment, the better their long-term outcomes were. (i)
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"The new analysis confirmed that in MS, timing of treatment is important. The findings showed that even if two patients are treated for an equivalent length of time, the one who started therapy earlier in the disease course had a better long-term outcome," said Douglas Goodin, MD, Director of the Multiple Sclerosis Center at UCSF Medical Center. "Patients and physicians should take these results into consideration when making treatment decisions."



A second study, called CogniMS, also presented at WCTRIMS, demonstrated that cognitive deficits can be measured early in the course of MS. (ii) The investigators suggested that such cognitive deficits may be clinically important for MS management decisions.



"Studies are now showing that apart from disease progression and relapse rates, cognition is another area that is impacted early in the course of the disease. In fact, there is a correlation between the level of disability at the start of treatment and cognitive function 16 years later. More research is needed to determine how treatment might benefit long-term cognitive outcome," said Dr. Goodin.



"The data presented here underscore the need to help patients start therapy earlier and stay on treatment for the long-term," said, Ludger Heeck, Ph.D. Vice President and General Manager, Specialty Medicine Bayer HealthCare Pharmaceuticals Inc. "Bayer is committed to helping provide both the medication and the support services that people need to help treat their MS. We pioneered the concept of customized MS support services, and our best-in-class BETAPLUS(TM) program goes far beyond treatment to offer a wide range of beneficial services for people with MS. From having dedicated MS nurses who can provide practical help and advice, to offering product enhancements like our new thinnest needle and optional autoinjector that can help make injection administration more comfortable, we continue to lead the way in helping people with MS start on and stay on treatment."



About the Trials

The 16-Year Long-term Follow-up Study is a multicenter observational study that collected data from patients with relapsing-remitting MS (RRMS) who participated in the pivotal North American trials for Betaseron. Several statistical methods were used to assess patient data and examine the relationship between timing of drug exposure and long-term outcomes. Drug exposure was measured as the medication possession ratio (MPR) defined as the actual time the patient received therapy divided by the total time possible before a negative outcome was reached (or at data censor). A statistical method called recursive partitioning was then used to divide treatment groups into "high" or "low" exposure and to determine the relationship between length of drug exposure and long-term ou
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